1. Field of the Invention
As established in and by the U.S. Patent Office, this invention is believed to be found in the classification of art directed to a sterile connector as applied for human and like use. This connector and package provides manipulation and a positive connection of a first half to an unused second half after a used second half is disconnected. Two embodiments are exemplified. One device uses a sliding actuation and one utilizes a movable ring.
2. Description of the Prior Art
A discussion of sterile connection devices has been made in the above-identified co-pending application, and additionally to be considered are U.S. Pat. Nos. 4,405,312 to GROSS et al, as issued Sept. 20, 1983; also known is 4,412,834 to KULIN et al, as issued Nov. 1, 1983; and 4,411,662 to PEARSON, as issued Oct. 25, 1983. All these patents show disengaging means or apparatus while proposing to insure sterility during operation. These showings require manipulation and, at times, the control leaves room for contamination from external conditions. The present invention provides a sterile connector package which is easily manipulated by an attendant and provides sterility at all times. This sterile connector package is relatively inexpensive and may be used by a patient for dialysis attachment or the like.
Coupling devices are well known and are particular to the field of use. Electrical connectors are widely used as are the connectors for fluid flow. The connector device of this invention is particularly used and useful for fluid flow in the field of medicine when and where sterility is to be maintained at the time of disconnect. Kidney deficiency or failure has led to the use of dialysis which requires repeated "hook-up" to the blood system or to the recently-adopted continuous ambulatory peritoneal dialysis. CAPD, "Continuous Ambulatory Peritoneal Dialysis," has been developed by the medical community and costs about one-half that of conventional dialysis. This CAPD is less traumatic to the body of the user, requires far less time and, more importantly, can be done at home. Under these circumstances, a sterile connecting device is especially important.
It is estimated that about fifty thousand people need dialysis treatment to live. CAPD uses a small, flexible catheter surgically implanted into the patient's abdominal cavity. A plastic bag containing the treating solution is attached to the catheter and through gravity this solution is fed through the catheter and into the bottom of said abdominal cavity. The emptied bag, although still attached, is now clamped and stored in the patient's pocket. The waste products in the blood are drawn by natural means into the solution. The impurity-laden fluid is then drained from the cavity into the bag which has now been placed on the floor. Although as many as four bags per day may be needed for cleansing the blood of a patient, the patient need but only half an hour to make each complete exchange and at the other times the patient is unencumbered. This exchange process is painless and the patient quickly becomes accustomed to the pressure of the dialysis fluid in the abdomen and in the use of this system.
A problem with this method and others using implanted catheters is the contamination developed by handling. It is essential that a sterile connector half as provided by the several embodiments of this invention insure that the catheter end be protected at the time of disconnection of the device.